Advanced Clinical Trials
BSTA5015
This elective unit extends and enhances the concepts developed in BSTA5006 Design of Experiments and RCTs. On completion, students have the knowledge and skills required at an advanced professional level to design and analyse clinical trials, including cross-over designs and equivalence trials, and to identify and implement statistical methods for trial monitoring and reporting, with appropriate knowledge of regulatory requirements. This unit covers: methods in RCTs for determining: stopping rules for interim analyses (O'Brien-Fleming, Peto), spending functions, stochastic curtailment; statistical principles encountered in relation to aspects of regulatory guidelines (ICH, FDA, EMEA), and related to reports prepared for data safety and monitoring committees (DSMC); design and analysis of cross-over trials (period effects, interactions); equivalence and non-inferiority trials; problems of defining and using surrogate endpoints as alternatives to direct clinical outcomes.
Unit of study details
Unit of study level: Postgraduate
Credit points: 6
Commencing semesters: 2
Further unit of study information
Unit of study handbook: BSTA5015
Costs and scholarships information: Costs and Scholarships
Final dates to withdraw from units of study: Census Dates
Available for study abroad and exchange: No